Duns Number:529915664
Device Description: Disposable Face Mask, White, non-sterlie, covering mouth and nose intends to use for prote Disposable Face Mask, White, non-sterlie, covering mouth and nose intends to use for protection in general public
Catalog Number
-
Brand Name
BBN
Version/Model Number
MR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
d4c0fdea-46cd-41cb-a8c5-16c898d7a45f
Public Version Date
April 12, 2021
Public Version Number
1
DI Record Publish Date
April 03, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |